This tibble contains artificial protocol deviation data for 180 subjects
in the Intent-to-Treat (ITT) population of the GT01 study. The dataset
contains the usual parameters (PARAM, PARAMCD) for an addv. There is
summary parameter (PARCAT1 == "OVERALL") for each subject of the GT01
ITT-population, indicating whether or not at least one major protocol
deviation (PD) occurred throughout the course of the study for the respective
subject. Individual records for protocol deviations per subject exist,
indicating which specific type of PD occurred. The additional flag CRIT1FL,
shows whether a PD was related to COVID-19 or not.
Although the data was intentionally created to mimic a typical clinical trial dataset following the CDISC format, it might not strictly comply with CDISC ADaM rules. The intent is to showcase the workflow for clinical table creation rather than creating a fully CDISC-compliant ADaM dataset.
Format
A tibble with 291 rows and 20 variables:
- STUDYID, STUDYIDN
The unique study identifier and its numeric version.
- USUBJID
The unique subject identifier.
- TRTA, TRTAN
The study intervention and its numeric version, which is either
"Placebo"(1),"Drug 1"(2), orNA(3), missing for screen failures).- ITTFL
Intent-to-Treat (ITT) population flag, where
"Y"indicates a subject belongs to the ITT population and"N"indicates a subject is not in the ITT population.- AGE
The age of a subject at baseline in years.
- AAGEGR1
The analysis age group, indicating if a subject was strictly younger than 40 years at baseline or older.
- SEX
Sex of a subject. Can be either
"Male","Female"or"Undifferentiated".- ETHNIC
Ethnicity of a subject. Can be either
"Hispanic or Latino","Not Hispanic or Latino"or missing ("").- BLBMI
Body Mass Index (BMI) of a subject at baseline in kg/m2.
- DVTERM
The Protocol Deviation Term.
- PARAMCD, PARAM
The Parameter Code and decoded parameter description for the protocol deviation.
- PARCAT1
Parameter category. Can be
"OVERALL"for derived PD summaries or"PROTOCOL DEVIATION"for individual PDs.- DVCAT
Category for PD, indicating whether the PD is a major one or not.
- ACAT1
Analysis category 1. Only populated for individual PDs, not for summary scores. High level category for PDs.
- AVAL
Analysis Value. Either
0or1.- CRIT1, CRIT1FL
Analysis Criterion 1 and analysis criterion 1 flag, indicating whether PD is related to COVID-19 or not.
Examples
dplyr::glimpse(rx_addv)
#> Rows: 291
#> Columns: 20
#> $ STUDYID <chr> "GT01", "GT01", "GT01", "GT01", "GT01", "GT01", "GT01", "GT01…
#> $ STUDYIDN <chr> "4001", "4001", "4001", "4001", "4001", "4001", "4001", "4001…
#> $ USUBJID <chr> "GT1001", "GT1002", "GT1002", "GT1003", "GT1003", "GT1003", "…
#> $ TRTA <fct> Placebo, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo…
#> $ TRTAN <dbl> 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1…
#> $ ITTFL <chr> "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "…
#> $ AGE <int> 41, 39, 39, 38, 38, 38, 45, 45, 35, 35, 35, 35, 35, 42, 35, 3…
#> $ AAGEGR1 <fct> >=40, <40, <40, <40, <40, <40, >=40, >=40, <40, <40, <40, <40…
#> $ SEX <fct> Male, Female, Female, Male, Male, Male, Male, Male, Female, F…
#> $ ETHNIC <fct> Not Hispanic or Latino, Not Hispanic or Latino, Not Hispanic …
#> $ BLBMI <dbl> 33.35073, 30.45862, 30.45862, 22.85986, 22.85986, 22.85986, 2…
#> $ DVTERM <chr> "", "", "Lab values not taken at month 3", "", "{gt} Question…
#> $ PARAMCD <fct> PDANYM, PDANYM, PDEV02, PDANYM, PDEV01, PDEV02, PDANYM, PDEV0…
#> $ PARAM <fct> At least one major Protocol Deviation, At least one major Pro…
#> $ PARCAT1 <chr> "OVERALL", "OVERALL", "PROTOCOL DEVIATION", "OVERALL", "PROTO…
#> $ DVCAT <chr> "", "", "Major", "", "Major", "Major", "", "Major", "", "", "…
#> $ ACAT1 <chr> "", "", "Study Procedures Criteria Deviations", "", "Study Pr…
#> $ AVAL <dbl> 0, 1, 1, 0, 1, 1, 1, 1, 0, 1, 1, 1, 1, 0, 1, 1, 1, 1, 0, 1, 1…
#> $ CRIT1 <chr> "COVID-19 Related", "COVID-19 Related", "COVID-19 Related", "…
#> $ CRIT1FL <chr> "N", "N", "N", "N", "N", "N", "N", "N", "N", "Y", "N", "N", "…